Phase III CORAL Study of SAGE 217 meets trial objectives in depression.

This significance was demonstrated at the first measured time point, Day 3, with zuranolone 50 mg co-initiated with an open-label standard of care antidepressant (ADT) as assessed by change from baseline in the 17-item Hamilton Rating Scale for Depression (HAMD-17).

The CORAL Study also met its key secondary endpoint, with zuranolone co-initiated with a standard of care ADT demonstrating a statistically significant improvement in depressive symptoms compared to ADT co-initiated with placebo, over the 2-week treatment period. Zuranolone was generally well-tolerated, and no new safety signals attributable to zuranolone were identified. In meeting its pre-defined objectives, the CORAL Study supports the potential of zuranolone, when co-initiated with standard of care, to accelerate the benefit of depression treatment compared to treatment with ADTs alone.

Based on consistent findings suggesting a benefit of zuranolone in people with MDD with elevated anxiety across the LANDSCAPE program, the CORAL Study prospectively examined this population. In this CORAL Study subgroup (n=218 of 425 people (51.3%) with HAM-A total score of at least 20 at baseline) zuranolone co-initiated with an ADT was nominally statistically significant to ADT with placebo in reducing depressive symptoms as measured by the primary endpoint (-9.3 compared to -6.0; HAMD-17 total score change from baseline) and key secondary endpoint (-11.7 compared to -9.4; HAMD-17 total score change from baseline) demonstrating the potential to address the unmet need for this population, which has been historically less responsive to chronically administered ADTs.